Exploring the Real-World Effectiveness of Empagliflozin and Linagliptin Fixed-Dose Combination in Type 2 Diabetes Patients of Bangladesh: A Prospective Multi-Center Observational Study

Purpose: The fixed-dose combination (FDC) of empagliflozin and linagliptin is a promising treatment for type 2 diabetes mellitus (T2DM), but real-world data from Bangladesh is limited. This study aimed to assess the effectiveness and safety of empagliflozin 10 mg/linagliptin 5 mg [Empa/Lina (10/5)] FDC among T2DM patients at real-world settings in Bangladesh. Patients and Methods: This prospective, multicenter, observational study enrolled 822 adults with T2DM across Bangladesh. Patients receiving Empa/Lina (10/5) FDC either alone or with other antidiabetic medications at practice were enrolled. Glycemic control, body mass index (BMI), blood pressure, and adverse events were assessed over three months. Results: Mean HbA1c decreased significantly from baseline to three months in both the Empa/Lina (10/5) FDC alone group (9.13% to 8.18%, p< 0.001) and the FDC plus other antidiabetics group (10.20% to 8.12%, p< 0.001). Fasting and post-prandial blood glucose levels also improved significantly (p< 0.001). BMI decreased from 26.81 kg/m 2 to 25.90 kg/m 2 (p=0.008). Systolic and diastolic blood pressure reduced by 11.09 mmHg and 4.41 mmHg, respectively (p< 0.001). The estimated glomerular filtration rate remained stable. Improvements were consistent across patient subgroups with various comorbidities. Adverse events were infrequent, with hypoglycemia (10.95%), genital mycotic infection (3.04%), and urinary tract infections (2.80%) being the most common. Conclusion: Empa/Lina (10/5) FDC demonstrated significant improvements in glycemic control, BMI, and blood pressure with a favorable safety profile in Bangladeshi patients with T2DM. These real-world findings support its use as an effective treatment option in this population.